Toraco Abdominal Aneurysm
Conditions
Keywords
surgical wound, Prevena System
Brief summary
The patients will be randomized into two groups of 100 subjects each one. One arm will be randomized to treatment with a negative topical pressure system (Sistema Prevena ™); while the other arm (control group) will be randomized to treatment with standard medication with sterile gauzes and a TNT patch or medicated patch as normal traditional medication in use. The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter the medication will be checked in the inpatient ward after 48 hours from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed. The medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery. For each evaluation the photograph of the medication must be taken (which will be deprived of all the identifying elements of the patient).
Interventions
DEVICESistema Prevena ™(TVAC)
The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter medication will be checked in the inpatient ward after 48 h from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed and renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery.
OTHERStandard medication
standard medication in use (sterile gauze and TNT patch or medicated patches).
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients over 18 years; * patients of any sex, race, age, who have accepted to participate in the study by signing the informed consent form of the study. * patients with surgical wounds to treat thoracic-abdominal aortic pathology.
Exclusion criteria
* patients with established sepsis; * patients with septic recurrence; * patients with sensitivity to silver.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of surgical site infections | 14 days after surgery | Decrease in the percentage of surgical site infections and / or surgical wound dehiscence within 14 days of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of adverse events | 12 month | decrease in the percentage of surgical reoperation |
Countries
Italy
Outcome results
None listed